Study Evaluating Predictive Value of Local Control at 19.8 (MRI and TEP Scan) for Patient With Stade IB2 and IIB Cervix Carcinoma Treated by Radiotherapy
Phase 2
18 Years
65 Years
18 Years
65 Years
Open (Enrolling)
Both
Cervix Cancer, Radiochemotherapy
Both
Cervix Cancer, Radiochemotherapy
Trial Information
Study Evaluating Predictive Value of Local Control at 19.8 (MRI and TEP Scan) for Patient With Stade IB2 and IIB Cervix Carcinoma Treated by Radiotherapy
Inclusion Criteria:
- cervix epidermoid cancer or adenocarcinoma(IB2, IIA, and IIB)
- treatment by radiochemotherapy
- tumor diameter at least 4 cm
- patient accepting not to smoke from 3 days prior to first cervix biopsies until end
of treatment
- ECOG ≤ 1
- social and psychological compliance for standard treatment of radiochemotherapy for
cervix carcinoma
- patient affiliated to health insurance system
- signed informed consent
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
change from baseline of value of persisting hypoxia at day 14
Outcome Description:
dynamic MRI : tumor volume, intensity of contrast enhancement (Ktrans and SI10 measurement) TEP scan : metabolic intensity, SUV measurement comparison of biopsie negativity
Outcome Time Frame:
Baseline, Day 14
Safety Issue:
No
Principal Investigator
Philippe NICKERS, MD PhD
Investigator Role:
Study Director
Investigator Affiliation:
Oscar Lambret Center
Authority:
France: Committee for the Protection of Personnes
Study ID:
ANOXICOL-1102
NCT ID:
NCT01641484
Start Date:
January 2012
Completion Date:
May 2019
Related Keywords:
- Cervix Cancer
- Radiochemotherapy
- Uterine Cervical Neoplasms
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